- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01504139
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
March 9, 2015 updated by: Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
- Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
- Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
- Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Detailed Description
The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.
Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central Jutland
-
Skive, Central Jutland, Denmark, 7800
- the Fertility clinic, Regional Hospital Skive
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women from the age of 25 up to 40
- Serum-FSH and serum-LH levels under 12 IU/L
- Length of period between 25 and 34 days
- BMI between 18 and 30
Exclusion Criteria:
- less than 2 ovaries
- uterine abnormalities
- PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hCG in the late follicular phase + luteal phase
|
when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).
|
Experimental: hCG in the follicular phase + luteal phase
|
hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.
|
Experimental: LH in the luteal phase
|
LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.
|
Active Comparator: vaginal progesterone and estradiol in the luteal phase
|
The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of progesterone in the mid-luteal phase.
Time Frame: up to 1-1½years.
|
up to 1-1½years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Helle Olesen Elbaek, The Fertility Clinic, Skive Regional Hospital, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
December 28, 2011
First Submitted That Met QC Criteria
January 4, 2012
First Posted (Estimate)
January 5, 2012
Study Record Updates
Last Update Posted (Estimate)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 9, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20110289
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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